Carboplatin and Gemcitabine in Treating Patients With Locally Advanced or Metastatic Breast Cancer

NCT00470249 | Terminated Phase 2

• 2 other identifiers: CDR00005426272005-005164-83
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 3

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as carboplatin and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving carboplatin together with gemcitabine works in treating patients with locally advanced or metastatic breast cancer.

Conditions

Breast Cancer

Keywords

stage IIIB breast cancer; stage IIIC breast cancer; stage IV breast cancer; recurrent breast cancer; male breast cancer; stage IIIA breast cancer

Outcome Measures

Primary Outcomes (1)

• Overall response rate (complete or partial response)

  Assess the Overall response rate (complete or partial response)

  8 months

Secondary Outcomes (5)

• Overall toxicity as assessed by NCI CTCAE v3.0

  8 months

• Overall survival

  8 months

• Time to disease progression

  8 months

• Duration of response

  8 months

• Time to treatment failure

  8 months

Study Arms (1)

Patients with (HER-2)-negative and anthracycline- and taxane-resistant

EXPERIMENTAL

Patients with human epidermal growth factor 2 (HER-2)-negative locally advanced or metastatic breast cancer that was anthracycline- and taxane-resistant

Drug: Carboplatin; Drug: Gemcitabine Hydrochloride

Interventions

Carboplatin DRUG

At a dose equivalent to an area under the concentration-time curve of 4.5 mg/ml.min on day 1 of every 2-week cycle

Patients with (HER-2)-negative and anthracycline- and taxane-resistant

Gemcitabine Hydrochloride DRUG

1500 mg/m2 on day 2 of every 2-week cycle

Patients with (HER-2)-negative and anthracycline- and taxane-resistant

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• DISEASE CHARACTERISTICS: histologically confirmed breast cancer, locally advanced or metastatic disease, recurrent or refractory disease, histological or cytological confirmation required for recurrence in a solitary site
• Must have received prior anthracycline and taxane as neoadjuvant, adjuvant, or metastatic therapy
• At least 1 measurable site of disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
• Palpable disease allowed, Lesions that have been irradiated in the advanced setting cannot be included as sites of measurable disease
• No nonmeasurable disease only, including the following:
• Bone lesions
• Leptomeningeal disease
• Ascites
• Pleural or pericardial effusion
• Inflammatory breast disease
• Lymphangitic pulmonary disease
• Abdominal masses that are not confirmed and followed by imaging techniques
• Cystic lesions
• No HER2-positive disease, defined as 3+ by IHC OR positive by FISH or chromogenic in situ hybridization
• Hormone receptor status not specified

Sponsors & Collaborators

• University of Southampton: lead

Study Sites (3)

Royal Bournemouth Hospital

Bournemouth, England, BH7 7DW, United Kingdom

Location

Portsmouth Oncology Centre at Saint Mary's Hospital

Portsmouth, England, PO3 6AD, United Kingdom

Location

Southampton General Hospital

Southampton, England, SO16 6YD, United Kingdom

Location

Related Links

• Publication of the results

MeSH Terms

Conditions

Breast Neoplasms; Breast Neoplasms, Male

Interventions

Carboplatin; Gemcitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Nicholas Murray, MD

  University Hospital Southampton NHS Foundation Trust

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In this non-randomized prospective trial, patients with human epidermal growth factor 2 (HER-2)-negative locally advanced or metastatic breast cancer that was anthracycline- and taxane-resistant were treated with carboplatin at a dose equivalent to an area under the concentration-time curve of 4.5 mg/ml.min on day 1 and gemcitabine 1500 mg/m2 on day 2 of every 2-week cycle. The primary end point was overall response rate.

Study Record Dates

• First Submitted: May 3, 2007
• First Posted: May 7, 2007
• Study Start: July 15, 2006
• Primary Completion: November 3, 2008
• Study Completion: November 3, 2008
• Last Updated: February 1, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)